Information Systems: Information Systems ( WEBCPIPIS )
Study the basic computer system lifecycle model including activities and software quality assurance practices in each phase, from data integrity and security measures, such as back-up archiving and retention requirements for data management systems with product and financial impact. For example, manufacturing execution systems (MES), laboratory information management systems (LIMS), electronic document management systems (EDMS), and enterprise resource planning (ERP) or manufacturing resource planning/material requirement planning (MRP).
Duration: 51 minutes
At the conclusion of this session, participants will have knowledge of:
Attendance Suggested for:
This course relates to the following CPIP™ Knowledge Element:
Instructor Biography Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field. He is currently assisting the FDA with its re-examination of 21 CFR Part 11, and is a member of the team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He is the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He has received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE’s GAMP®5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Council, GAMP Editorial Board, and the GAMP Europe Steering Committee. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated healthcare industries. Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry.